HEMLIBRA Access Solutions offers a range of access and reimbursement resources for your patients and practice after HEMLIBRA is prescribed, including help with benefits investigations (BIs), resources for prior authorizations (PAs), sample billing and coding information, resources for denials and appeals, information about distribution and referrals to potential financial assistance options.
Get help understanding insurance benefits and coverage, such as with benefits investigations and prior authorization resources.
HEMLIBRA Access Solutions can conduct a benefits investigation (BI) which can determine:
*If your patient’s request for a prior authorization is not granted, your HEMLIBRA Access Solutions Specialist can work with you to determine your next steps.
Get started with enrollment by following the steps below.
If your practice has a registered account for My Patient Solutions, you can get started by logging into your account.
Don't have an account?
Your patient is required to complete the Patient Consent Form. You can either upload their Patient Consent Form as part of your application or have your patient submit the form via fax, text or e-submit.
An online tool to help you enroll patients in HEMLIBRA Access Solutions and manage your service requests at your convenience
Step 1: Print one of the Patient Consent Forms below for your patient to complete.
Step 2: Print and complete the Prescriber Service Form below.
Step 3: Submit the completed forms via fax or text.
Both forms are required. We must have both the Patient Consent Form and the Prescriber Service Form before we can help you.
What to expect next:
Genentech reserves the right to modify or discontinue the program at any time and to verify the accuracy of information submitted.
The completion and submission of coverage- or reimbursement-related documentation are the responsibility of the patient and healthcare provider. Genentech makes no representation or guarantee concerning coverage or reimbursement for any service or item.
When a medical treatment is authorized by the patient’s insurance plan for a limited period of time, it will generally require reverification of coverage for continued treatment. HEMLIBRA Access Solutions can help you obtain reverification for your patients.
If the patient’s health insurance plan denies the request for reverification, your practice may file an appeal on behalf of your patient.
Sample coding information and resources for denials and appeals
This coding information may assist you as you complete the payer forms for HEMLIBRA. These tables are provided for informational purposes only. Please visit CMS.gov or other payers’ websites to obtain additional guidance on their processes related to billing and coding.
Download sample coding and the important safety information for HEMLIBRA below.
Correct coding is the responsibility of the provider submitting the claim for the item or service. Please check with the payer to verify codes and special billing requirements. Genentech does not make any representation or guarantee concerning reimbursement or coverage for any service or item.
If your patient’s health insurance plan has issued a denial, your HEMLIBRA Access Solutions Specialist can provide resources as you prepare an appeal submission, as per your patient’s plan requirements.
If a plan issues a denial:
A sample appeal letter and additional considerations are available on the Practice Forms and Documents page.
Appeals cannot be completed or submitted by Genentech on your behalf.
My Patient Solutions is an online tool to help you enroll patients in HEMLIBRA Access Solutions and manage your service requests, all through one portal. It allows you the flexibility to work with HEMLIBRA Access Solutions when it’s convenient for you.
With My Patient Solutions, you can:
How to register
Account registration can be completed by one person for the entire practice and for multiple practice locations. For help with registration or if you have questions, call us at 877-GENENTECH (877-436-3683) (6AM-5PM PST, Monday through Friday).
HEMLIBRA Access Solutions works with specialty pharmacies (SPs) to help patients receive their prescribed Genentech medicines.
In addition to distributing medicines, an SP may provide the following services:
You can work with your preferred SP or contact HEMLIBRA Access Solutions to learn which SP the patient’s health insurance plan mandates or prefers.
Genentech does not influence or advocate the use of any one specialty distributor or specialty pharmacy. We make no representation or guarantee of service or coverage of any item. For any product-specific distribution questions, call HEMLIBRA Access Solutions at 877-233-3981 (6AM-5PM PST, Monday through Friday).
HEMLIBRA package insert. South San Francisco, CA: Genentech, Inc.; 2024.
HEMLIBRA package insert. South San Francisco, CA: Genentech, Inc.; 2024.
FDA Approves Genentech’s HEMLIBRA (emicizumab-kxwh) for Hemophilia A Without Factor VIII Inhibitors. Genentech Press Release. South San Francisco, CA: Genentech; October 4, 2018.
FDA Approves Genentech’s HEMLIBRA (emicizumab-kxwh) for Hemophilia A Without Factor VIII Inhibitors. Genentech Press Release. South San Francisco, CA: Genentech; October 4, 2018.
Data on File. Genentech, Inc.
Data on File. Genentech, Inc.
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Young G, Liesner R, Chang T, et al. A multicenter, open-label phase 3 study of emicizumab prophylaxis in children with hemophilia A with inhibitors. Blood. 2019;134(24):2127-2138. doi:10.1182/blood.2019001869
Young G, Sidonio R, Oldenburg J, et al. Efficacy/safety in children on 2/4-weekly emicizumab prophylaxis: 52-week outcomes in HAVEN 2. Presented at the American Society of Pediatric Hematology/Oncology (ASPHO) Conference; May 4-7, 2022; Pittsburgh, Pennsylvania.
Young G, Sidonio R, Oldenburg J, et al. Efficacy/safety in children on 2/4-weekly emicizumab prophylaxis: 52-week outcomes in HAVEN 2. Presented at the American Society of Pediatric Hematology/Oncology (ASPHO) Conference; May 4-7, 2022; Pittsburgh, Pennsylvania.
Shima M, Nagao A, Taki M, et al. Long-term safety and efficacy of emicizumab for up to 5.8 years and patients’ perceptions of symptoms and daily life: A phase 1/2 study in patients with severe haemophilia A. Haemophilia. 2021;27(1):81-89. doi:10.1111/hae.14205
Shima M, Nagao A, Taki M, et al. Long-term safety and efficacy of emicizumab for up to 5.8 years and patients’ perceptions of symptoms and daily life: A phase 1/2 study in patients with severe haemophilia A. Haemophilia. 2021;27(1):81-89. doi:10.1111/hae.14205
Shima M, Nogami K, Nagami S, et al. A multicentre, open-label study of emicizumab given every 2 or 4 weeks in children with severe haemophilia A without inhibitors. Haemophilia. 2019;25(6):979-987. doi:10.1111/hae.13848
Shima M, Nogami K, Nagami S, et al. A multicentre, open-label study of emicizumab given every 2 or 4 weeks in children with severe haemophilia A without inhibitors. Haemophilia. 2019;25(6):979-987. doi:10.1111/hae.13848
Négrier C, Mahlangu J, Lehle M, et al. Emicizumab in people with moderate or mild haemophilia A (HAVEN 6): a multicentre, open-label, single-arm, phase 3 study. Lancet Haematol. 2023;10(3):e168-e177. doi:10.1016/S2352-3026(22)00377-5
Négrier C, Mahlangu J, Lehle M, et al. Emicizumab in people with moderate or mild haemophilia A (HAVEN 6): a multicentre, open-label, single-arm, phase 3 study. Lancet Haematol. 2023;10(3):e168-e177. doi:10.1016/S2352-3026(22)00377-5
Pipe SW, Collins P, Dhalluin C, et al. Emicizumab prophylaxis in infants with hemophilia A (HAVEN 7): primary analysis of a phase 3b open-label trial. Blood. 2024;143(14):1355-1364. doi:10.1182/blood.2023021832
Pipe SW, Collins P, Dhalluin C, et al. Emicizumab prophylaxis in infants with hemophilia A (HAVEN 7): primary analysis of a phase 3b open-label trial. Blood. 2024;143(14):1355-1364. doi:10.1182/blood.2023021832
Jiménez-Yuste V, Peyvandi F, Klamroth R, et al. Safety and efficacy of long-term emicizumab prophylaxis in hemophilia A with factor VIII inhibitors: A phase 3b, multicenter, single-arm study (STASEY). Res Pract Thromb Haemost. 2022;6(8):e12837. doi:10.1002/rth2.12837
Jiménez-Yuste V, Peyvandi F, Klamroth R, et al. Safety and efficacy of long-term emicizumab prophylaxis in hemophilia A with factor VIII inhibitors: A phase 3b, multicenter, single-arm study (STASEY). Res Pract Thromb Haemost. 2022;6(8):e12837. doi:10.1002/rth2.12837
Efficacy, safety, and pharmacokinetic study of prophylactic emicizumab versus no prophylaxis in hemophilia A participants (HAVEN 5). Clinicaltrials.gov identifier: NCT03315455. Updated September 25, 2024. Accessed November 19, 2024. https://clinicaltrials.gov/ct2/show/NCT03315455.
Efficacy, safety, and pharmacokinetic study of prophylactic emicizumab versus no prophylaxis in hemophilia A participants (HAVEN 5). Clinicaltrials.gov identifier: NCT03315455. Updated September 25, 2024. Accessed November 19, 2024. https://clinicaltrials.gov/ct2/show/NCT03315455.
Kitazawa T, Esaki K, Tachibana T, et al. Factor VIIIa-mimetic cofactor activity of a bispecific antibody to factors IX/IXa and X/Xa, emicizumab, depends on its ability to bridge the antigens. Thromb Haemost. 2017:117(7):1348-1357. doi:10.1160/TH17-01-0030
Kitazawa T, Esaki K, Tachibana T, et al. Factor VIIIa-mimetic cofactor activity of a bispecific antibody to factors IX/IXa and X/Xa, emicizumab, depends on its ability to bridge the antigens. Thromb Haemost. 2017:117(7):1348-1357. doi:10.1160/TH17-01-0030
Callaghan MU, Negrier C, Paz-Priel I, et al. Long-term outcomes with emicizumab prophylaxis for hemophilia A with or without FVIII inhibitors from the HAVEN 1-4 studies. Supplement. Blood. 2021;137(16):2231-2242. doi:10.1182/blood.2020009217
Callaghan MU, Negrier C, Paz-Priel I, et al. Long-term outcomes with emicizumab prophylaxis for hemophilia A with or without FVIII inhibitors from the HAVEN 1-4 studies. Supplement. Blood. 2021;137(16):2231-2242. doi:10.1182/blood.2020009217
Callaghan MU, Negrier C, Paz-Priel I, et al. Long-term outcomes with emicizumab prophylaxis for hemophilia A with or without FVIII inhibitors from the HAVEN 1-4 studies. Blood. 2021;137(16):2231-2242. doi:10.1182/blood.2020009217
Callaghan MU, Negrier C, Paz-Priel I, et al. Long-term outcomes with emicizumab prophylaxis for hemophilia A with or without FVIII inhibitors from the HAVEN 1-4 studies. Blood. 2021;137(16):2231-2242. doi:10.1182/blood.2020009217
National Bleeding Disorders Foundation. MASAC Document 268: Recommendation on the use and management of emicizumab-kxwh (HEMLIBRA) for hemophilia A with and without inhibitors. April 27, 2022; New York, NY.
National Bleeding Disorders Foundation. MASAC Document 268: Recommendation on the use and management of emicizumab-kxwh (HEMLIBRA) for hemophilia A with and without inhibitors. April 27, 2022; New York, NY.
McCary I, Guelcher C, Kuhn J, et al. Real-world use of emicizumab in patients with haemophilia A: bleeding outcomes and surgical procedures. Haemophilia. 2020;26(4):631-636. doi:10.1111/hae.14005
McCary I, Guelcher C, Kuhn J, et al. Real-world use of emicizumab in patients with haemophilia A: bleeding outcomes and surgical procedures. Haemophilia. 2020;26(4):631-636. doi:10.1111/hae.14005
Kruse-Jarres R, Peyvandi F, Oldenburg J, et al. Surgical outcomes in people with hemophilia A taking emicizumab prophylaxis: experience from the HAVEN 1-4 studies. Blood. 2022;6(24):6140-6150. doi: 10.1182/bloodadvances.2022007458
Kruse-Jarres R, Peyvandi F, Oldenburg J, et al. Surgical outcomes in people with hemophilia A taking emicizumab prophylaxis: experience from the HAVEN 1-4 studies. Blood. 2022;6(24):6140-6150. doi: 10.1182/bloodadvances.2022007458
Oldenburg J, Mahlangu JN, Kim B, et al. Emicizumab prophylaxis in hemophilia A with inhibitors. N Engl J Med. 2017;377(9):809-818. doi:10.1056/NEJMoa1703068
Oldenburg J, Mahlangu JN, Kim B, et al. Emicizumab prophylaxis in hemophilia A with inhibitors. N Engl J Med. 2017;377(9):809-818. doi:10.1056/NEJMoa1703068
Oldenburg J, Mahlangu JN, Kim B, et al. Emicizumab prophylaxis in hemophilia A with inhibitors. Supplement. N Engl J Med. 2017;377(9):809-818. doi:10.1056/NEJMoa1703068
Oldenburg J, Mahlangu JN, Kim B, et al. Emicizumab prophylaxis in hemophilia A with inhibitors. Supplement. N Engl J Med. 2017;377(9):809-818. doi:10.1056/NEJMoa1703068
Ebbert PT, Xavier F, Seaman CD, Ragni MV. Emicizumab prophylaxis in patients with haemophilia A with and without inhibitors. Haemophilia. 2020;26(1):41-46. doi:10.1111/hae.13877
Ebbert PT, Xavier F, Seaman CD, Ragni MV. Emicizumab prophylaxis in patients with haemophilia A with and without inhibitors. Haemophilia. 2020;26(1):41-46. doi:10.1111/hae.13877
Hassan E, Jonathan L, Jayashree M. Real-world experience on the tolerability and safety of emicizumab prophylaxis in paediatric patients with severe haemophilia A with and without FVIII inhibitors. Haemophilia. 2021;27(6):e698-e703. doi:10.1111/hae.14432
Hassan E, Jonathan L, Jayashree M. Real-world experience on the tolerability and safety of emicizumab prophylaxis in paediatric patients with severe haemophilia A with and without FVIII inhibitors. Haemophilia. 2021;27(6):e698-e703. doi:10.1111/hae.14432
Schmitt C, Emrich T, Chebon S, et al. Low immunogenicity of emicizumab in persons with haemophilia A. Haemophilia. 2021;27(6):984-992. doi:10.1111/hae.14398
Schmitt C, Emrich T, Chebon S, et al. Low immunogenicity of emicizumab in persons with haemophilia A. Haemophilia. 2021;27(6):984-992. doi:10.1111/hae.14398
Mahlangu J, Jiménez-Yuste V, Ventriglia G, et al. Long-term outcomes with emicizumab in hemophilia A without inhibitors: results from the HAVEN 3 and 4 studies. Res Pract Thromb Haemost. 2024;8(2):102364. doi:10.1016/j.rpth.2024.102364
Mahlangu J, Jiménez-Yuste V, Ventriglia G, et al. Long-term outcomes with emicizumab in hemophilia A without inhibitors: results from the HAVEN 3 and 4 studies. Res Pract Thromb Haemost. 2024;8(2):102364. doi:10.1016/j.rpth.2024.102364
Di Minno A, Spadarella G, Nardone A, et al. Attempting to remedy sub-optimal medication adherence in haemophilia: the rationale for repeated ultrasound visualisations of the patient’s joint status. Blood Rev. 2019;33:106-116. doi:10.1016/j.blre.2018.08.003
Di Minno A, Spadarella G, Nardone A, et al. Attempting to remedy sub-optimal medication adherence in haemophilia: the rationale for repeated ultrasound visualisations of the patient’s joint status. Blood Rev. 2019;33:106-116. doi:10.1016/j.blre.2018.08.003
Schrijvers LH, Schuurmans MJ, Fischer K. Promoting self-management and adherence during prophylaxis: evidence-based recommendations for haemophilia professionals. Haemophilia. 2016;22(4):499-506. doi:10.1111/hae.12904
Schrijvers LH, Schuurmans MJ, Fischer K. Promoting self-management and adherence during prophylaxis: evidence-based recommendations for haemophilia professionals. Haemophilia. 2016;22(4):499-506. doi:10.1111/hae.12904
Manco-Johnson MJ, Abshire TC, Shapiro AD, et al. Prophylaxis versus episodic treatment to prevent joint disease in boys with severe hemophilia. N Engl J Med. 2007;357(6):535-544. doi:10.1056/NEJMoa067659
Manco-Johnson MJ, Abshire TC, Shapiro AD, et al. Prophylaxis versus episodic treatment to prevent joint disease in boys with severe hemophilia. N Engl J Med. 2007;357(6):535-544. doi:10.1056/NEJMoa067659
National Bleeding Disorders Foundation. MASAC Document 267: MASAC Recommendation Concerning Prophylaxis for Hemophilia A and B with and without Inhibitors. April 27, 2022; New York, NY.
National Bleeding Disorders Foundation. MASAC Document 267: MASAC Recommendation Concerning Prophylaxis for Hemophilia A and B with and without Inhibitors. April 27, 2022; New York, NY.
Pipe S, Collins P, Dhalluin C, et al. Emicizumab Prophylaxis in Infants with Severe Hemophilia A without Factor VIII Inhibitors: Results from the Primary Analysis of the HAVEN 7 Study. Slide deck presented at: 65th ASH Annual Meeting; December 9-12, 2023; San Diego, California.
Pipe S, Collins P, Dhalluin C, et al. Emicizumab Prophylaxis in Infants with Severe Hemophilia A without Factor VIII Inhibitors: Results from the Primary Analysis of the HAVEN 7 Study. Slide deck presented at: 65th ASH Annual Meeting; December 9-12, 2023; San Diego, California.
Ljung R, de Kovel M, van den Berg HM on behalf of the PedNet study group. Primary prophylaxis in children with severe haemophilia A and B—Implementation over the last 20 years as illustrated in real-world data in the PedNet cohorts. Haemophilia. 2023;29(2):498-504. doi:10.1111/hae.14729
Ljung R, de Kovel M, van den Berg HM on behalf of the PedNet study group. Primary prophylaxis in children with severe haemophilia A and B—Implementation over the last 20 years as illustrated in real-world data in the PedNet cohorts. Haemophilia. 2023;29(2):498-504. doi:10.1111/hae.14729
Mahlangu J, Oldenburg J, Paz-Priel I, et al. Emicizumab prophylaxis in patients who have hemophilia A without inhibitors. N Engl J Med. 2018;379(9):811-822. doi:10.1056/NEJMoa1803550
Mahlangu J, Oldenburg J, Paz-Priel I, et al. Emicizumab prophylaxis in patients who have hemophilia A without inhibitors. N Engl J Med. 2018;379(9):811-822. doi:10.1056/NEJMoa1803550
HEMLIBRA Summary of Product Characteristics. Roche Registration Limited; 2022.
HEMLIBRA Summary of Product Characteristics. Roche Registration Limited; 2022.
Kruse-Jarres R, Peyvandi F, Oldenburg J, et al. Surgical outcomes in people with hemophilia A taking emicizumab prophylaxis: experience from the HAVEN 1-4 studies. Supplementary materials. Blood Adv. 2022;6(24):6140-6150. doi:10.1182/bloodadvances.2022007458
Kruse-Jarres R, Peyvandi F, Oldenburg J, et al. Surgical outcomes in people with hemophilia A taking emicizumab prophylaxis: experience from the HAVEN 1-4 studies. Supplementary materials. Blood Adv. 2022;6(24):6140-6150. doi:10.1182/bloodadvances.2022007458
HEMLIBRA Instructions For Use. Roche Registration Limited; 2022.
HEMLIBRA Instructions For Use. Roche Registration Limited; 2022.
Doyle GR, McCutcheon JA. Clinical Procedures for Safer Patient Care. Victoria, BC: BCcampus. 2015. Retrieved from https://opentextbc.ca/clinicalskills/
Doyle GR, McCutcheon JA. Clinical Procedures for Safer Patient Care. Victoria, BC: BCcampus. 2015. Retrieved from https://opentextbc.ca/clinicalskills/
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